telaprevir

Vertex readies new Phase 3 trial of telaprevir

John Carroll — Tue, 19 Aug 2008 12:09:56 -0400

Vertex and partner Johnson & Johnson have struck agreements with regulators on both sides of the Atlantic for a new Phase III trial of the closely-watched telaprevir for hepatitis C. This new late-stage study will test the therapy in 650 refractive patients and is intended to build on the data due from a separate trial of telaprevir in treatment naïve patients.

Vertex's share price has been tied to the fate of telaprevir, rising and falling with the drug's prospects. TheStreet notes that the developer isn't likely to file for approval of the drug until the second half of 2010, when it has the data on the treatment naïve group. A smaller study in treatment resistant patients has demonstrated efficacy for attacking the virus.

--see the Vertex release
--read the story from TheStreet.com

Schering-Plough posts positive hep C data

John Carroll — Mon, 04 Aug 2008 12:12:20 -0400

Schering-Plough published promising new data for its experimental hepatitis C drug boceprevir, which pushed down the share value of rival Vertex Pharmaceuticals. After 48 weeks of therapy, researchers said, three out of every four patients receiving boceprevir in combination with standard therapy had undetectable levels of the virus. That compares to 38 percent with undetectable viral levels in the standard therapy arm.

None of that Phase II data is likely to sway analysts who pegged Vertex's closely watched telaprevir as the likely winner in the race to an FDA approval. But hepatitis C is a very competitive disease field, and a rival therapy could quickly eat into its revenue. Vertex shares lost 11 percent on the news from Schering-Plough.

- check out Schering-Plough's release
- read the report from StreetInsider

Vertex shares rise on positive data for telaprevir

John Carroll — Mon, 09 Jun 2008 11:52:41 -0400

Vertex Pharmaceuticals saw a significant bump in its share price this morning after researchers released new, mid-stage interim data backing telaprevir for hepatitis C. The company is now penciling in the start of a new late-stage trial for the closely watched drug--enrolling patients who had failed standard therapy--in the third quarter. The new data is from a Phase IIb involving patients who had failed a standard therapy.

In the study, patients received telaprevir in combination with interferon/ribavirin for 12 weeks, then the combination therapy for the next 12 weeks followed by 12 weeks of neither therapy. The control arm received the combination therapy for 36 weeks. Slightly more than half of the telaprevir group had undetectable levels of the virus after 36 weeks compared to 30 percent in the control group. A late stage trial for the hep C drug began in spring with patients who had received no prior therapy.

- check out the press release
- read the AP report